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Original Article

Automatic Transport Ventilator Versus Bag


Valve in the EMS Setting: A Prospective,
Randomized Trial
Steven J Weiss, MD, Amy A. Ernst, MD, Ray Jones, EMT-P, Margaret Ong, RN,
Todd Filbrun, EMT-P, Chad Augustin, EMT-P, Mike Barnum, MD, and Todd G. Nick,

Purpose: The primary objective of this study was to compare Emergency Medical Technicians-Paramedics (EMT-P) perceptions of the
usefulness of an automatic transport ventilator (ATV) compared
with bag valve (BV) ventilation for intubated patients.
Methods: Cardiopulmonary resuscitation or assisted ventilation patients were randomly assigned by day to the ATV or BV arm of the
study. Questionnaires were completed by the EMT-Ps at the conclusion of each patient enrollment. EMT-Ps were asked to rate the
modality used (ATV versus BV) on ease of use, time of setup,
expedition of transport, additional tasks completed, documentation,
overall patient care, and patient comfort.
Results: Twenty-eight patients were entered into the study, 14 in the
BV arm and 14 in the ATV arm. There were significant differences
in favor of the ATV in ability to accomplish additional tasks (P
0.01), ability to document (P 0.04), and ability to provide patient
care (P 0.03)
Conclusions: EMT-Ps were able to accomplish more tasks, document more completely, and provide better patient care with the use
of the ATV.
Key Words: emergency medical services, ventilation, end-tidal CO2,
critical care

From the University of New Mexico Health Sciences Center, Albuquerque,


New Mexico; Sacramento City Fire/EMS, Sacramento, California; and
Center for Epidemiology & Biostatistics, Cincinnati Childrens Hospital
Medical Center, Cincinnati, Ohio and the University of Cincinnati College of Medicine, Cincinnati, Ohio.
Reprint requests to Steven Weiss, MD, University of New Mexico, MSC10
5560, Albuquerque, NM 87131-0001. E-mail: Sweiss52@aol.com
Accepted April 1, 2005.
Supported by an unrestricted gift from Vortran Medical. The monitoring
equipment was donated through the generosity of Oridian, Inc, and
Physiocontrol Corporation. The authors also wish to acknowledge Taltech
Industries who developed the PC programming to collect data from the
monitoring device.
Presented at the Society for Academic Emergency Medicine, May 2004.
Copyright 2005 by The Southern Medical Association
0038-4348/02000/9800-0970

970

PHD

afe, effective airway management is the single most important skill performed by prehospital personnel. In the
past, most mechanical ventilators were electronically driven.1
More recently, a number of devices that are gas-driven have
appeared on the marketplace.2,3 These devices are simple to
use, effective, and inexpensive.2 Previous studies have shown
that transport ventilators are better at maintaining minute volume4 and pre/postarterial blood gas results.2,5 However, no
one has evaluated ongoing oxygen saturation and the ability
of Emergency Medical Service (EMS) crews to perform other
functions. We are seeking to determine whether a gas-powered ventilator is a valuable asset to EMS once a definitive
airway has been established.1,3,510 If a gas-powered ventilator could be used for airway support, the result could be an
improvement in patient ventilation, patient care, and oxygenation during transport.
The hypotheses of this study were that (1) paramedics
prefer the use of a gas-powered respirator over the use of a
bag valve (BV) and that (2) measures of ventilation and oxygenation can be successfully recorded by EMS personnel
during transport

Materials and Methods


This was an unblinded, randomized, prospective study
comparing two ventilatory methods in intubated patients.
The study device used was the Vortran Automatic Resuscitator (VAR), which is a single-patient, disposable, gaspowered, automatic resuscitator. The VAR provides constant-

Key Points
Use of an automatic transport ventilator allowed EMTs
to accomplish extra tasks, document better, and provide better patient care.
Side effects are no different between the automatic
transport ventilator and the bag valve.
Physiological data can be effectively gathered during
field care of intubated patients.

2005 Southern Medical Association

Original Article

flow, pressure-cycled ventilation. It can be used in either the


pressure support or pressure control modes. A manometer
provides real time airway pressure figures. The device includes a 60 cm H2O pop-off valve that will actuate in the
unlikely event of a pressure overload. For clarity, the VAR
will be called an automatic transport ventilator (ATV) for the
remainder of this report. Both the ATV and the BV were
FDA-approved devices for ventilatory management that were
used successfully in other environments. The cost of the VAR
is less than $100. Figure 1 shows the ventilator.
Patients were included if they were at least 18 years of
age and endotracheal intubation was successful. Patients under the age of 18 or those weighing less than 40 kg were
excluded, as the ATV is not approved for those patients.
Entry included those intubated for either CPR or assisted
ventilation.
The independent variable was the use of either the ATV
or the BV to ventilate a patient. The dependent variables were
the following: (1) successful management, as determined clinically by ease of use of the device, ability to accomplish
additional tasks, ability to complete additional monitoring,
ability to provide more thorough documentation, and overall
assessment of the performance of the device as measured by
a Likert scale completed by paramedics after transport; and
(2) effectiveness of oxygenation and ventilation, as determined by pulse oximetry and capnometry.
All cases were analyzed with the use of an intention-totreat methodology. Ambulance units were assigned to use the
ATV or the BV resuscitator as their method of ventilatory
support for a 24-hour period, based on a list of random numbers. The device unpacked and packaged for use is shown in
Figure 2, A and B.
After random assignment, the data collection device was
connected to all subjects to collect physiological data. Pulse,
oxygen saturation, respiratory rate, and end-tidal CO2 were
collected every 5 seconds and converted into an Excel file for
analysis.
At the receiving hospital, the intervention phase of the
study ceased and the hospital management was based on physician choice of care. The study information form was filled
out for each patient, indicating condition of the patient, activities of the paramedics, and outcome. The questions deter-

Fig. 1 Vortran disposable pressure-powered ventilator used in

Fig. 2 Data collection device laid out to show all of the parts (A)
and packed for use by the EMS providers (B). Comparison with
a Bic pen in B shows the relatively small size of the packet
carried by EMS.

mined paramedic opinion on the ventilation method used in


comparison to the other method (2 much worse, 1
worse, 0 the same, 1 better, 2 much better). Complications were followed in an ongoing manner, and the study
would be stopped if there was a significant difference in
complications between the two groups. In the event that the
gas-powered ventilator was not working successfully, the patients airway management reverted to ventilatory management with a BV.
Confounding variables of experience with BV and variation from standard techniques in placement were avoided by
training everyone equally and using a break-in period at the
beginning of the study to allow EMS personnel to gain familiarity in using the gas-powered ventilators.
The University Investigational Review Board approved
the study. This study was waived from informed consent,
based on minimal risk. We were unable to obtain consent
because patients entered into the study had extreme distress at
the time when the study device was used. Both the BV and
the ATV are FDA-approved devices for patient ventilation.
This study qualified for a waived consent for the following
reasons: (1) there was minimal risk associated with either
device; (2) the waiver would not adversely affect the rights or
welfare of the subjects; (3) the study could not be practically
performed without the waiver; (4) whenever possible, the
subjects were provided with additional pertinent information
after participation, if warranted.
Although multiple manufacturers funded the study and
loaned the devices to the investigators, none had any say in
study design, implementation, write-up, or publication. No
study investigator was associated with any of these companies or received any compensation.
Statistical analysis was performed by using a Mann-Whitney U test for nonparametric data and a Pearson 2 for dichotomous data. All values were considered significant at a
value of P 0.05.

the study.
Southern Medical Journal Volume 98, Number 10, October 2005

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Weiss et al EMS Use of a Gas-Powered Ventilator

Results
Twenty-eight patients were entered into the study, 14 in
the BV arm and 14 in the ATV arm. The reason for device use
was assisted ventilation in 7 of 28 (25%) cases and CPR in 21
of 28 (75%) cases.
There were no significant differences in the EMS perception of ease of use (P 0.08), time of setup (P 0.14),
expedition of transport (P 0.27), or overall patient care
(P 0.59). There were significant differences in favor of the
ATV in ability to accomplish additional tasks (P 0.01),
ability to document (P 0.04), and ability to provide patient
care (P 0.03). These are illustrated in Table 1.
Problems occurred only rarely and did not affect the
outcomes of any of the patients. Table 2 lists the problems
and percentages for each of the groups. More of the problems
were with charging or recording properly on the data collection unit. These were not listed in the table because they did
not pertain to the ATV or BV ventilation devices.
The data collection unit was able to record ongoing physiological data on 15 of 28 (54%) patients during EMS transport. Reasons for lack of data collection were run times that
were too short and inability to operate the data collection unit.
Table 3 lists the patients who had data successfully recorded,
data type, and period of time.

Case studies
The following two cases illustrate the results obtained
and the utility of noninvasive physiological monitoring of
patients during EMS transports.
Patient 1: ATV
EMS was called to the house of a 58-year-old male for
the complaint of the patient being unresponsive (Fig. 3). The
patient was found slumped over in a friends vehicle when the
friend drove him to the firehouse. He was placed on a backboard and gurney. Because he was pulseless and apneic, CPR

was initiated and the patient was intubated. En route, the


patient went through multiple rhythm changes, including asystole, pulseless electrical activity, and ventricular fibrillation.
He received 1 mg epinephrine 2, 1 mg atropine 2, and
electric shocks 3. At arrival to the Emergency Department
(ED), he had a strong carotid pulse without any change in
level of consciousness or respirations. The graphic results,
shown in Figure 3, illustrate the high values for end-tidal CO2
and how they increase dramatically on restoration of a pulse.
The patient survived.
Patient 2: Bag valve
EMS was called for a 79-year-old diabetic male for
complaint of unresponsiveness (Fig. 4). The patient was
found lying unresponsive on the ground. Because he was
pulseless and apneic, CPR was initiated and the patient
was intubated. En route, the patient received 1 mg epinephrine 3, and 1 mg atropine 2. There were no
changes in the patients condition during transport. At arrival to the ED, he was declared dead on arrival by the ED
staff. The graphic results shown in Figure 4 illustrate how
a rhythm appeared for a short time, but end-tidal CO2
never increased significantly, and the patient died.

Discussion
We found that EMT-Ps perceived that certain aspects of
their job (tasks, documentation, and patient care) were easier
when ATV was attached to the patient. We also found a trend
toward perceived ease of use and time to setup in favor of the
BV. This was not surprising, considering that ATV use was
a newly learned skill. Both end-tidal CO2 and oxygen saturation could be monitored during EMS transport.
There is a great deal of literature on the use of end-tidal
CO2 during CPR and mechanical ventilation.1118 Most have
suggested that a low CO2 has prognostic value during CPR.
Garnett et al18 say that end-tidal CO2 with ventilation held

Table 1. Likert scale comparison for EMT-P perceptions of the two airway management devices used in this study.
Higher mean scores and higher mean ranks represent more paramedics favorably rating that device (see text for
scoring system)
Automatic transport
ventilator (ATV)

Ease of use
Amount of time to set up ventilation equipment
Expedition of transport
Accomplishing additional tasks
Ability to document activities clearly and quickly
during the transport
Patient comfort
Ability to provide overall patient care

Bag valve (BV)

Mean score

Mean rank

Mean score

Mean rank

0.8
0.6
0.3
0.6
0.2

11.89
12.36
15.93
18.21
17.36

0.4
0.2
0.0
0.3
0.3

17.11
16.64
13.07
10.79
11.64

0.08
0.14
0.27
0.01*
0.04*

0.0
0.4

16.50
16.36

0.4
0.0

12.50
12.64

0.20
0.03*

*Significant at P 0.05.

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2005 Southern Medical Association

Original Article

Table 2. Comparison of problems with the ATV and BV ventilatory devices


For automatic transport
ventilator (ATV) (N 14)
Loss of airway before ED (up to when patient
turned over to ED physician)
Evidence of aspiration
Evidence of device failure
Inability to correctly use device
Oxygen ran out
Difficulty performing CPR

For bag valve


(BV) (N 14)

P*

0 (0%)

0 (0%)

1.00

3
2
3
0
2

0
0
0
0
0

0.22
0.48
0.22
1.00
0.48

(21%)
(14%)
(21%)
(0%)
(14%)

(0%)
(0%)
(0%)
(0%)
(0%)

Pearson 2 (P 0.05 is significant).

Table 3. Table of physiological data recorded during EMS transport for each of the four variables in the 28
patients entered into the study. Plus () indicates acceptable data was recorded; minus (-) indicates unacceptable or
no data recordeda
Ventilation
group
ATV

CPR or assisted
ventilation (AV)
CPR

AV
BV

CPR

AV

Patient No.

ET CO2

1
2
9
10
14
15
16
17
20
21
26
27
8
18
3
4
6
13
22
23
24
25
5
12
19
28

Resp rate

O2 sat

Heart rate

Minutes
recorded
3
nd
nd
nd
10
nd
9
nd
13
8
nd
nd
9
nd
nd
3
15
8
nd
7
9
nd
16
12
1
5

nd, no data were collected in these cases.

constant tracked changes in perfusion and that the real-time


tracking of events with this device led to rapid and successful
pharmacological intervention in the case they describe. The
two cases described in this report differed primarily in the
end-tidal CO2 (ETCO2) values, the other three variables were
Southern Medical Journal Volume 98, Number 10, October 2005

minimally different. The survivor (patient 1) had higher


ETCO2 during the entire transport. Then, just before the documentation of spontaneous circulation, there was a rise in the
ETCO2 to values greater than 60. On the other hand, the
nonsurvivor had very low ETCO2 levels except for an in-

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Weiss et al EMS Use of a Gas-Powered Ventilator

Fig. 3 Results shown using data collection device with monitor in a case using the automated transport ventilator.

Fig. 4 Results shown using data collection device with monitor in a case using the bag valve ventilator.

crease in values to 35 about 1 to 2 minutes before ED arrival.


Our results agree with these other studies that the differences
in outcome seem to be related to ETCO2; however, the graphs
indicate that a single level and a particular time would be
oversimplifying the results and could lead to the wrong conclusion. Following ETCO2 over time would lead to more
appropriate use of the results.

974

The difficulties associated with BV ventilation during


scene management are important to describe. Any time a
patient requires positive-pressure ventilation in the prehospital setting, at least one member of the EMS team must manually operate the BV resuscitator. This loss of a team member
to such a crucial, singular duty can add difficulty to the transport. Delays can occur due to the loss of manpower to tasks
2005 Southern Medical Association

Original Article

such as extrication, patient portage over obstacles such as


stairs, and even due to the difficulty of moving the gurney
into and out of the ambulance. The utilization of resources is
suboptimal when a skilled provider is dedicated solely as the
ventilator. Clearly, this strain on manpower is most acute for
two provider teams, which require one team member to drive
while the other shoulders the entire burden of patient care. In
this case, management of the resuscitator completely monopolizes the providers time to the exclusion of intravenous
access, secondary survey, management of injuries, and additional patient assessment.
It is unknown how lapses in optimal ventilation affect
patient oxygenation. During these instances when manpower
is short, patient ventilation is relegated to a secondary concern. Hurst et al19 examined 28 patients requiring transport in
a prospective, randomized fashion, comparing manual ventilation with ventilation provided by a transport ventilator. After manual ventilation, all patients showed a marked respiratory alkalosis, whereas after ventilation with the transport
ventilator there were no appreciable changes in pH or PaCO2.
Based on these results, the authors suggested the superiority
of automated transport ventilators in this setting.
In addition to the extra tasks that could be accomplished
and the stabilization of acid-base status, there is an advantage
to transport ventilators in stabilizing the ventilatory rate. Dockery et al8 found that during intrahospital transport, BV ventilation resulted in greater fluctuation of ventilatory parameters from
an established baseline than did use of a transport ventilator,
which was important for adequate resuscitation.
A critical outcome of this study was to determine whether
we could successfully move the laboratory into the prehospital setting and monitor patient data during EMS transport.
We were able to successfully monitor patients for up to 18
minutes of transport times, only limited by the length of our
longest call. The machines worked well at collecting every
5-second heart rate, respiratory rate, end-tidal CO2, and oxygen saturation. Using this technology, the number of studies
assessing the outcome of prehospital interventions could increase dramatically.
We only found a few problems with the ATV, none of
which reached statistical significance. There was an inability
to correctly use the device by a number of the paramedics.
Four cases in which device failure or inability to use the
device was recorded were actually failure of the data collection device. These were not recorded as outcome problems
because they were unrelated to the ventilator use. Many were
charging problems because both the monitor and the data
collection device required frequent charging cycles and stayed
charged for only short periods of time.
A limitation of the study was the complexity of the setup
required for data monitoring. The setup included a fairly complex monitoring system that itself took additional time, energy, and knowledge. The system required not only the placement of the monitoring devices, one on the airway and one on
Southern Medical Journal Volume 98, Number 10, October 2005

the patients finger, but also required the EMT-P to turn on


both the data collector and the monitor and wait for both to
warm up and set up correctly. It then required verification
that data were being produced and exported by the monitor
and that the data were received and recorded on the data
collector. Although these steps were necessary for the research collection, in general these multiple complex steps
would not be part of the setup and therefore resulted in study
bias. We believe that our compliance level was lower because
of this difficult set of steps. Newer marketed devices can
monitor this information internally and may offer a better
solution in the future.
Operators preexisting bias for or against each device is
unavoidable in a study such as this. The study could not be
blinded. However, we found that the opinions of the paramedics at the outset of the study were mixed, suggesting no
particular bias on their part.
Finally, our ability to generalize these results to other
systems is limited by the technology available to that system
and the training of the EMS responders.

Conclusion
EMT-Ps were able to accomplish more tasks, document
more completely, and provide better patient care with the use
of the ATV. The ATV can be used successfully during field
resuscitation and transport. The data collector was able to
collect physiological data, time-mark it, and store it for subsequent retrieval in a majority of cases. This type of monitoring system is feasible to collect physiological data in the
EMS setting.

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Think not those faithful who praise all thy words and
actions; but those who kindly reprove thy faults.
Socrates

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